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BAF_FRontier-1Safety and Efficacy of LY4152199 in Previously Treated B-cell Lymphoma

Study Aim

This phase 1 study aims to evaluate the safety of LY4152199 by observing the number of previously treated B-cell Lymphoma patients who experience dose limiting toxicities.

What is being tested

LY4152199 - IV

Drug

Who is being recruted

Hemic and Lymphatic Diseases+9

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorEli Lilly and Company

Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on a drug called LY4152199, which is being tested for adults who have previously treated B-cell lymphoma, a type of cancer affecting the immune system's B-cells. The main goal is to find the most suitable dose of LY4152199 that is safe and effective for these participants. This research holds importance as it aims to address the current need for improved treatments for B-cell lymphoma.

Official TitleBAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies

NCT07101328

Principal SponsorEli Lilly and Company

Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

215 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellLymphoma, Large B-Cell, Diffuse

Criteria

1 inclusion criteria required to participate

Must have failed or were intolerant to at least 2 prior lines of therapy appropriate for available treatment for the specific B-cell malignancy

4 exclusion criteria prevent from participating

Significant cardiovascular disease

History of autoimmune disease

Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Escalating doses of LY4152199 administered intravenously (IV)

Group II

Experimental

Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Group III

Experimental

Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 50 locations

Suspended

City of Hope

Duarte, United StatesOpen City of Hope in Google Maps

Suspended

University of Colorado Denver - School of Medicine - Anschutz Medical Campus

Aurora, United States

Suspended

Colorado Blood Cancer Institute

Denver, United States

Suspended

Yale University School of Medicine - Yale Cancer Center

New Haven, United States

Recruiting soon50 Study Centers